Clearance Summary
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP received FDA 510(k) clearance under submission number K110343, sponsored by Mayborn Baby and Child / Jackel International, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2011-03-11.
- Submission: K110343
- Applicant / Sponsor: Mayborn Baby and Child / Jackel International, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2011-03-11
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.